ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error
ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect 'may lead to serious adverse health consequences' due to under-delivery of critical medication, which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk scenarios warranting a Severe classification.
Plain-English summary
ICU Medical, Inc. is recalling 675 units of REF: MC330424 IV administration sets. The recall involves a specific lot number (4168883) and a specific UDI. The affected product is a 145-inch (368 cm) primary set with a 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R.
The recall is due to a potential manufacturing error where the sets may contain a 15 drops/mL drop cannula instead of the intended 10 drops/mL drop cannula within the drip chamber. This discrepancy could result in inaccurate delivery of the intended infusion volume, specifically under-delivery. Under-delivery of critical medication may lead to serious adverse health consequences.
The affected units were distributed to various US states including AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, and WY, as well as to Canada. Healthcare providers and facilities should check their inventory for the specific lot number and UDI listed in the recall notice and stop using the affected units if found.
The recalled product
- Product
- REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 675
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: 4168883
Distribution
Part of a larger recall action
This product is one of 10 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
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